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NCT06896344Recruiting

Role of Mesenchymal Stromal Cell Derived Extracellular Vesicles of Primary Myelofibrosis Patients on CD34+ Cells

Microenvironment Cross-talk: Role of Extracellular Vesicles Derived From Mesenchymal Stromal Cells of Patients With Primary Myelofibrosis in Modifying Functional Activities of CD34+ Hematopoietic Progenitor Cells

Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The aim of this study is to demonstrate that, in patients with myelofibrosis (PMF), a chronic neoplastic disease of the bone marrow, some of the cells that form the bone marrow microenvironment (mesenchymal stromal cells, MSCs) can send wrong messages to the CD34+ hematopoietic progenitor cells (HPCs). CD34+ HPCs in normal conditions reside in the bone marrow until complete maturation; in PMF they leave the bone marrow when they are still progenitor cells and frequently they express the V617F mutation on the JAK2 molecule. In previously published papers, the investigators demonstrated that the MSCs in the bone marrow of patients with PMF are different from those in healthy donors. In this study the investigators want to verify how this difference affects the maturation of CD34+ HPCs of healthy donors and of SET2 cells, a commercially available cell line characterized by the V617F mutation of the JAK2 molecule. In particular, the investigators will verify the effect of MSCs on signals that induce the activation of CD34+ cells, their survival or death, the production of harmful oxidative reagents and their clonal capacity. To obtain these data, the investigators will isolate MSCs from bone marrow blood samples of patients with PMF undergoing bone marrow biopsy for clinical reasons and from healthy subjects, donors of HPCs for transplant. Following a long culture MSCs will be stimulated to release small vescicles containing part of their nuclear and cytoplasmatic molecules. These vescicles will be cultured with CD34+ cells or SET2 cells and their effects will be evaluated. It has been shown that these small vescicles act exactly like MSCs, but they are easier to be used, and could become a very useful acellular drug in the near future.

Status (registry)
Recruiting
Study type
Observational
Enrollment
10 (estimated)
First submitted
6 Mar 2025
Start date
11 Jan 2024
Primary completion date
Jun 2025
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
NCT number
NCT06896344

What you commit to

  • Study type: Observational
  • Planned participants: 10
  • From 11 Jan 2024 to the primary completion date, Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous splenectomy
  • Previous bone marrow transplant

Other

  • PMF combined to other pathologies

Who the study is looking for

  • Patients with PMF
  • JAK2 V617F+ (either homozygous or heterozygous)
  • Out of therapy
  • At least 18 years old

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Fondazione IRCCS Policlinico San Matteo di Pavia
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PaviaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.